Pharmaceutical Manufacturing, Scale Up and Tech transfer:


The biopharmaceutical sector in US enjoys 17% of all domestic R&D funded by the country and in return gave $2.5 trillion cumulative addition in economic output in 2016. Companies engaged in the brand name pharmaceutical manufacturing have grappled in recent years owing to the largest waves of drug patent expirations in history. As a consequence enabling low-price generic drugs to inundate the market.  Many brand name pharmaceutical manufacturers have contended with intensifying competition from generic manufacturers, cutting into revenue growth. Until the next the five years till 2022, investments in research and development that generate a high return will occur as many pharmaceutical manufacturers strengthen their drug pipeline with orphan drugs.



Recently, process engineers have shown inclination to single-use, modular and continuous manufacturing technologies to improve efficiency and minimize scale-up and technology transfer challenges in the pharmaceutical industry. Lot of these innovations are driven by updates instigated by the FDA. The changes are inevitable; especially in the already aging biopharmaceutical sector of the industry, where original processes are often overly complex, and are characterized by inefficiency, and occasionally, inherent unpredictability.



 


  • Challenges in pharma manufacturing
  • ICH Q10
  • Knowledge transition between development and manufacturing sites
  • Tech transfer protocols and guidelines
  • Tech transfer key considerations
  • Challenges in tech transfer

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